US20070161867A1

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Publication number: US20070161867A1
Application number: US11/329,910
Authority: US
Inventors: James Fowler; Marc Gelnett; Kevin Bowen
Original assignee: Lone Star Medical Products Inc
Current assignee: CooperSurgical Inc
Priority date: 2006-01-11
Filing date: 2006-01-11
Publication date: 2007-07-12

Abstract

The present invention provides a retractor system useful in a wide variety of surgical procedures. This retractor system includes an annular retractor frame that can be used in conjunction with a bridge member or bridge frame to modify the positions available for the attachment of stays during a surgical procedure. In addition, the present invention provides a novel deep tissue blade for use with the annular retractor frame and the bridge member.

Description

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to surgical retractors and surgical retractor stays or blades. More particularly, the present invention relates to an annular retractor frame adapted for receiving and securing an end portion of an elastic member of a surgical retractor stay or blade. The present invention further relates to a bridge connecting two points or areas of the annular retractor frame which is adapted for receiving and securing an end portion of an elastic member of a surgical retractor stay or blade.

2. Description of Related Art

During the course of many surgical procedures, tissue surrounding an incision or wound is separated and retracted by means of retractors or stay sutures, which are generally held by trained assistants. Most retractors are one piece metallic implements that retract a wound in a non-yielding manner. Many retractors retract the wound in a manner such that manipulation and movement by the surgeon as well as movement caused by contracting muscles or tissues of the patient can result in bruising or tearing of the tissue. Once the tissue is separated and retracted, further stabilizing, retracting, or delivering of exposed tissues or organs, requires the placement of additional retractors or stay sutures. Nevertheless, the use of these sutures and attached devices can clutter the surgical field for the surgeon and can be difficult to maintain in their desired positions due to the variations in the skills of the operating staff, especially in cases where the surgery takes an extended period of time.

Several retractor systems have been developed that require less continual maintenance by the physician and staff. Many of these embody devices designed for a designated area of the body on which surgery is to be performed without causing undue visual or physical obstructions.

More recently, elastic surgical retractor systems have come into commercial use that include elastic stays, each having an elongated elastic member that is typically a hollow length of elastic tubing. The elastic tubing provides proximal and distal end portions. The distal end portion typically carries an elongated hook constructed of wire which is placed in the distal end of the bore of the hollow tubing. In many instances, a shrink wrap is placed over the hook and tubing to hold the proximal end of the wire hook firmly in position within the bore of the tubing at the distal end. The embedded portion of the wire hook member is usually recurved or folded. This folded proximal portion of the wire hook can expand the tubing slightly, forming a vertically extended portion that defines a handle.

Various patents have issued for elastic stay retractor systems. A surgical retractor array system is disclosed in U.S. Pat. No.: 4,434,791, issued to W. Dale Darnell on Mar. 6, 1984. This surgical retractor system comprises an array of standardized, interchangeable, annular retractor frame sections of various shapes of which the end portions are configured to permit the interchangeable, hinged connection of the various shaped frames in forming generally annular retractor units adaptable to conform to fit the surface contours of various patients upon which a surgical operation is to be performed. This retractor frame is designed to accept yielding rubber or like elastic stays.

Other patents have issued that relate to elastic type retractor stays and related retractor frames and systems. For example, U.S. Pat. No.: 4,274,398, issued to Frank B. Scott, Jr., on Jun. 23, 1981, which is hereby incorporated by reference, discloses a surgical retractor which includes an annular frame conformed to fit the surface contour of the portion of the body to be operated on. At least one stay includes an elastic member and a tissue holding hook. The frame has a plurality of notches spaced about its periphery. The elastic portion of the stay is in the form of a length of hollow elastic tubing adapted to be inserted into one of the notches of the frame and held in place by friction to retract the tissue. The hook is a single, curved wire member. It has a folded proximal end that fits the hollow bore of the elastic tube.

U.S. Pat. No.: RE 32,021, issued to Frank B. Scott, Jr., on Nov. 5, 1985, which is hereby incorporated by reference, discloses a surgical retractor which includes a frame conformed to fit the surface contour of the portion of the body to be operated on and at least one stay which includes an elastic member and tissue holding means. The frame, furthermore, has a plurality of notches spaced about its periphery and the elastic member of the stay is adapted to be inserted into one of the notches and held in place by friction to retract the tissue.

In addition, United States Patent Application Pub No.: US2005/0171405A1, published on Aug. 4, 2005, which is hereby incorporated by reference, provides a surgical retractor system having annular frame and at least one support member attached to the annular frame in a notch based attachment system, wherein at least a portion of the support member extends over at least a portion of the inner area of the frame.

Despite these disclosures, a need remains for a retractor system that provides a maximized area for stable attachment of elastic stays and is capable of securely lifting and holding large tissue segments without causing undue injury to such tissue.

SUMMARY OF THE INVENTION

The present invention provides a surgical retractor system for use in performing surgery that includes a generally annular retractor frame having at least one notch; a hinged region and a flanged region. The retractor of the present invention further includes a bridge member having at least one notch and at least one seating structure that can be attached to the hinged region of the annual retractor frame. The retractor frame of the present invention can be used with at least one elastic stay or blade attached to the annular retractor frame or the bridge member, wherein the at least one elastic stay or blade includes a tissue holding means attached to an elastic member.

Certain embodiments of the surgical retractor system include a bridge member that also has a securing structure on which the at least one thumb-screw or wing-nut tightens down. In still other embodiments, the bridge member can be non-pliable, semi-malleable and/or disposable.

DESCRIPTION OF THE FIGURES

FIG. 1 shows a retractor frame and several elastic stays.

FIG. 2 shows a retractor frame with a hinged region.

FIG. 3 shows an elastic stay.

FIG. 4 depicts the use of a retractor frame and elastic stays during a surgical procedure.

FIG. 5 shows one embodiment of a retractor frame with a bridge member.

FIG. 6 shows one embodiment of a bridge member.

FIG. 7 shows one embodiment of a deep tissue blade.

FIG. 8 shows a retractor frame being used with one embodiment of a deep tissue blade.

FIG. 9 shows an alternate embodiment of a deep tissue blade.

DESCRIPTION OF THE INVENTION

The present invention includes a retractor having a generally annular frame1. One embodiment is depicted inFIGS. 1 and 2. In certain embodiments, the outer edge of theretractor2 includes at least one, and preferably a plurality, ofnotches3. Thenotches3 are operable as connection points between the retractor frame1 and at least onestay4. Thenotches3, in some embodiments, can be modified to hold or retain sutures.

The annular frame1 further includes aproximal side5 and adistal side6. The retractor frame1 of the present invention can be formed of any suitable material. In certain embodiments, the frame is composed of a non-pliable material. In some embodiments, the retractor frame1 is reusable and composed of a material that can be sterilized and re-sterilized, such as stainless steel, titanium, aluminum, or other suitable metals. In alternate embodiments, the retractor frame1 is disposable and composed of a material such as a plastic material that is sufficiently strong to support the use of multiple stays that are connected thereto without altering the shape of the frame1. These embodiments can be pre-sterilized and packaged for delivery to the surgeon.

In certain embodiments the frame1 may be shaped such that thedistal side5 of the frame1 conforms to fit the surface contours of a specific portion of the body to be operated upon (as shown inFIGS. 2 and 4). In certain of these embodiments, the annular frame includes a hingedregion7 and an outwardly extendingflanged portion8 which can be utilized to further contour the annular frame to the region of the body to be operated on. The extendingflanged portion8 of the frame1 can be maintained in any intermediate position by friction within the hingedregion7 between it and frame1, or by other suitable mechanical means well-known in the art such as a thumb-screw or wing-nut. Furthermore, theflanged portion8 can be any shape, including, but not limited to, circular, triangular or non-symmetrical configurations.

Alternate embodiments of the present invention include an annular frame1 composed of suitable semi-pliable or malleable material(s). Suitable semi-pliable materials include materials that are capable of being molded into a particular shape while at the same time possessing enough resistance to shape changes to allow proper tension to be exerted on a retractor by an elastic stay or blade. Such materials include, but are not limited to, certain plastics and/or malleable metals such as nitinol. In these embodiments, the shape of the retractor may be modified to correspond to the contour of the bodily region to be operated on.

In certain embodiments, the frame1 (including the outwardly extendingflange portion8 if present) may include a plurality ofnotches3 about the outer edge. In some of these embodiments, the width and depth of eachnotch3 is such thatelastic portion9 of a stay4 (as shown inFIG. 3) may be inserted therein and held in place by friction without damaging theelastic portion9.

In certain embodiments of the present invention, eachstay4 includes an elongated, flexibleelastic member9 that is connected to a tissue-holdingdevice10. In some embodiments, theelastic member9 comprises a section of silicon rubber tubing or solid silicone cylinder. In still other embodiments, the stay includes a suture or other suitable line in place of the silicon rubber tubing. The tissue-holding device may be ahook10 as shown inFIG. 3. In certain of these embodiments, thehook10 includes ashank portion11 and arecurved handle portion12. The recurvedhandle portion12 can be inserted into the lumen of theelastic member9 for those embodiments utilizing silicon rubber tubing. The shape ofhandle portion12 can be designed to provide a convenient means by which a surgeon can manipulatehook10.

The operation of the retractor of the present invention is depicted inFIG. 4 which illustrates the use of retractor1 to expose thebladder12. After making an initial incision, a surgeon would use a pair ofstays4 to open the wound. The surgeon can control the tension applied to the edges of the wound by the tension or stretching of theelastic member9 of thestays4 when secured in thenotches3. As the surgeon proceeds through deeper layers of tissue, the wound is pulled further open by the tension ofelastic members9, and if the direction or force of the tension that is necessary needs to be changed, the surgeon can quickly do so simply by removing and reinserting the tissue-holding device, such as ahook10 and/or by movingelastic member9 to adifferent notch3.

In certain embodiments, the retractor of the present invention also includes abridge member13 that can be used to cross or bridge at least a portion of the inner opening of the annular retractor frame (as shown inFIG. 5). Thebridge member13 can be made of the same types of materials as the retractor frame1. Thebridge member13 can also be sterilizable and therefore reusable or can be provided in a disposable format. Furthermore, thebridge member13 can be provided in a multitude of shapes and sizes. One embodiment of such abridge member13 is depicted inFIGS. 5 and 6 having aninner edge15 and anouter edge16, as well as aproximal surface17 and adistal surface18. In alternative embodiments, the bridge member can include a hinged section between its two ends allowing the structure to partially or completely fold in upon itself.

In certain embodiments, the bridge member removably connects between two points on theinner edge14 of the retractor frame1. In some embodiments, thebridge member13 has aninner edge15 and anouter edge16 with respect to proximity to the incision location. Theinner edge15 and/or theouter edge16, in some of these embodiments, includes at least one, and preferably a plurality, ofnotches3. In certain embodiments the retractor frame1 andbridge member13 include a plurality of notches sufficient to provide a surgeon with incremental attachment points for the elastic member of a stay(s) or sutures.

In those embodiments of the retractor frame1 that include a hingedregion7 and an extendingflanged portion8, the bridge member can connect across the inner area of the retractor frame from one hingedregion7 to another as depicted inFIG. 5. Thebridge member13 can connect to the retractor frame1 through any suitable mechanism. For example, thebridge member13 can be designed to have a mating portion on each end that would allow the bridge member to snap into a variety of locations within the retractor frame1. In such embodiments, the retractor frame1 would also include structures, such as slots, preconfigured for accepting the mating portion of thebridge member13.

In other embodiments such as the one depicted inFIG. 6, the bridge member can be secured to the hinged region through a thumb-screw or wing-nut type mechanism. In such embodiments, the bridge member can further include aseating structure19 located on one end for tethering or stabilizing thebridge member13 to one side of the hinged region and a securingstructure20 on the other end for securing the bridge member to the retractor frame1. The securingstructure20 can be of any configuration that will provide sufficient stability in the attachment of thebridge member13 to the retractor frame1. In certain embodiments theseating structure19 and securingstructure20 are configured to increase the torsional stiffness of thebridge member13. Torsional stiffness of thebridge member13 decreases the potential twisting in relation to the retractor frame1. Such embodiments of thebridge member13 can provide more stable platforms for the attachment of rigid hand-held retractors. The bridge member can have anadditional seating structure21 on either or both ends.

In alternate embodiments, thebridge member13 can be a permanent feature of the retractor frame1. In certain of these embodiments, thebridge member13 is non-moveable. For example, thebridge member13 can be permanently affixed to the retractor frame1 or can be cast as a unitary portion of the retractor frame1. In some of these embodiments, the bridge member1 is permanently attached (either affixed thereto or cast as an integral feature) to the retractor frame1 on one side. In such embodiments, the free end of thebridge member13 can be reversibly attached to the frame through any suitable method.

The present invention further provides a deep tissue or Deaver-like blade for use with the retractor frame1 and/or thebridge member13.FIG. 7 depicts one embodiment of thedeep tissue blade22. The deep tissue blade includes aretractor attachment area23 and acurved section24. In certain embodiments, the deep tissue blade can also include an extension section from the proximal end of thecurved section24. Theattachment area23 is used to tether or attach the blade to the retractor frame1 by attaching to an elastic tether through an attachment structure. In certain embodiments, the attachment structure includes at least onecurved slot26 for attachment of anelastic tether27 as shown inFIG. 8. In certain of these embodiments, theattachment area23 includes threecurved slots26 that may be utilized individually or in combination. One of ordinary skill in the art will readily understand a variety of configurations could be used to attach the elastic tether to the attachment area and that such structures are encompassed by the present disclosure.

In certain embodiments, the attachment area also includesguides30 for the elastic tether(s)27 (seeFIG. 7). These guides30 can be of any shape or size sufficient to prevent the elastic tether from rolling under theguide30 during use. In certain embodiments, theguide30 includes abeveled edge31 extending proximally toward the end of the attachment area and a flat section that can be used as a fulcrum when theguide30 is used in such a fashion as to make contact with the retractor frame1 providing a downward force on thedeep tissue blade22 to pull the tissue laterally away from the surgical opening. In embodiments containing aguide30, theelastic tether27 can be looped onto the interior of one of thecurved slots26 and run inside theguide30 to attach to thedeep tissue blade22. Theguides30 will keep theelastic tether27 underneath theattachment area23 from its point ofattachment26 until theelastic tether27 is proximal of theguides30. This distance paired with the force of the tether will create a moment arm that directs thedistal end25 of thecurve24 downward and lateral to help it hold the tissue. Theelastic tether27 can then be used to determine the tension thedeep tissue blade22 puts on the tissue during use by adjusting the length of theelastic tether27 between thedeep tissue blade22 and the attachment of theelastic tether27 to the retractor frame1 or anotch3 in the retractor frame1 (as shown inFIG. 8). In still other embodiments, theattachment area23 includes a fulcrum structure (without the guiding aspect with respect to the elastic tether27) located on the distal side or edge of theattachment area23 to provide a downward force on thedeep tissue blade22 to pull the tissue laterally from the surgical opening. Aguide30 or a fulcrum structure can be positioned anywhere on the distal surface or outer edge of theattachment area23 to provide a variety of guiding functionalities or fulcrum forces. In certain embodiments the fulcrum structure is distal to the actual point of attachment for theelastic tether27. Furthermore, the fulcrum structure can be in a number of shapes or sizes, that would be readily ascertainable by one of ordinary skill in the art. For example, the fulcrum structure can be in the form of a rail extending across the attachment area or a series of one or more pyramids on the distal surface of the attachment area. In some embodiments theguide30 can act as the fulcrum structure. In still other embodiments the fulcrum structure is an integral part of theguide30.

Thedistal end25 of thecurved section24 can have any shape. In certain embodiments, thedistal end25 is blunted or rounded, while in still others it can be flared (either away from or toward the attachment area23). Furthermore, theinterior surface28 of thecurved section24 can have a variety of traction enhancing features. For example, the interior surface can also include at least one rib, spike or hatching to enhance its ability to secure tissue during use.

Thecurved section24, in certain embodiments, also includes a reflexed or beadededge29. In some of these embodiments, thebeaded edge29 prevents the deep tissue blade from cutting into the tissue and/or reduces potential distortions of the curved section during use. One of ordinary skill in the art will readily recognize that multiple shapes and features, which are encompassed by the present disclosure, would provide these same functions.

Thedeep tissue blade22 can be of any size suitable for use with a given retractor frame1. In certain embodiments, the internal opening between thedistal end25 of thecurved section24 and the distal surface of the attachment area23 (or extension area in certain embodiments) can range from 20 mm to 25 cm, while in preferred embodiments it can range from 3 cm to 10 cm. In certain of these embodiments, the width of thedeep tissue blade22 can also range from 2 cm to 8 cm. In some of these embodiments, the width of thecurved section24 can be greater than the width of theattachment area23.

The length of thecurved section24 can vary depending upon the deep tissue blades intended application and the distance between the internal opening between thedistal end25 of thecurved section24 and the distal surface of theattachment area23. In certain embodiments, the length of the curved section can range from 3 cm to 25 cm, while in preferred embodiments it can range from 6 cm to 12 cm.

The thickness of the deep tissue blade can vary depending upon its material composition and should be sufficient to minimize or eliminate shape distortions during use. In certain embodiments, the thickness of the deep tissue blade can range from 0.05 to 2 inches for embodiments composed of Noryl® plastic, aluminum, steel. In certain embodiments, thedeep tissue blade22 is composed of 0.1 inch thick disposable Noryl®.

In certain alternate embodiments, the shape of thecurved section24 ofdeep tissue blade22 can vary from an arch having a range of 90 to 200 degrees to a triangular apex with varying angles and side lengths. In still other embodiments, the shape of the curved section can be determined by a series of flat or relatively flat sections joined at angles to one another (open polygon). For example the curved section in some embodiments can resemble an open-ended box.

In certain embodiments, thecurved section20 can be separated intofingers32 giving the deep tissue blade22 a claw-like appearance such as shown inFIG. 9. In still other embodiments, the curved section can be divided into a series of spikes or spindles decreasing the actual contact area between thedeep tissue blade22 and the tissue while maintaining a wide section of tissue retraction during use. In certain of these embodiments, thedeep tissue blade22 also includes raised ridges on thefinger32 to increase resistance to deformation.

In still other embodiments, thedeep tissue blade22 can include a spacer section between theattachment area23 and thecurved section24. The spacer section can be of any suitable length for use with a given sized retractor frame1. In certain embodiments, the spacer section can range from greater than 0 cm to 5 cm.

From the foregoing, it can be seen that the retractor of the present invention increases greatly the efficiency and effectiveness of the surgeon. At least one member of the surgical team is eliminated, thereby reducing the expense to the patient. Moreover, by eliminating the need for an assistant directed by the surgeon, the surgeon is able to proceed more quickly, which results in further cost savings. Also, substantial benefits to the physical wellbeing of the patient are achieved by the use of the retractor of the present invention. The precise control that the surgeon has over the placement of and tension applied to the retracting devices minimize trauma during the course of the operation.

Further modifications and alternative embodiments of the retractor of this invention will be apparent to those skilled in the art in view of this description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the manner of carrying out the invention. Various changes that may be made in the shape, size and arrangement of parts are encompassed by the current disclosure.

Claims

1. A surgical retractor system for use in performing surgery comprising:

a generally annular retractor frame having an inner edge; an outer edge containing at least one notch; a hinged region and a flanged region;

a bridge member having an edge with at least one notch and at least one seating structure that can be attached to the hinged region of the annual retractor frame; and

at least one elastic stay or blade attached to the annular retractor frame or the bridge member, wherein the at least one elastic stay or blade includes a tissue holding means attached to an elastic member.

2. The surgical retractor system ofclaim 1, wherein the bridge member further includes a securing structure on which the at least one thumb-screw or wing-nut tightens down.

3. The surgical retractor system ofclaim 2, wherein the securing structure is in the shape of a flat open-ended circle.

4. The surgical retractor system ofclaim 3, wherein a seating structure of bridge member is on an opposite side from the securing structure.

5. The surgical retractor system ofclaim 3, wherein a seating structure of bridge member is on both ends of the bridge member.

6. The surgical retractor system ofclaim 2, wherein the bridge member is non-pliable.

7. The surgical retractor system ofclaim 2, wherein the bridge member is semi-malleable.

8. The surgical retractor system ofclaim 2, wherein the bridge member is disposable.

9. The surgical retractor system ofclaim 2, wherein the seating structure and securing structure increase the torsional stiffness of the bridge member in relation to the retractor frame.

10. The surgical retractor ofclaim 9, wherein the bridge member acts as a platform of attachment of the retractor frame to a handheld retractor.

11. The surgical retractor system ofclaim 1, wherein the bridge member further includes an internal hinged region to allow the bridge to fold up on itself.

12. The surgical retractor system ofclaim 1, wherein the bridge member is permanently attached to one side of the hinged region of the generally annular frame.

13. A surgical retractor comprising:

a closed retractor frame having an inner edge; an outer edge; two hinged regions, wherein at least one of the hinged regions includes a thumb-screw or wing-nut based mechanism that when tightened restricts its movement, and a flanged region;

a bridge member having two edges and two ends, wherein the bridge member further includes a seating region on at least one end that can be attached to the closed retractor frame and a securing structure on at least one end that can be tightened down on by a one thumb-screw or wing-nut associated with the hinged region of the closed retractor frame; and

at least one elastic stay or blade attached to the annular retractor frame or the bridge member, wherein the at least one elastic stay includes a tissue holding means attached to an elastic member.

14. The surgical retractor ofclaim 13 wherein the blade includes an elastic tether attachment area and a fulcrum structure on the distal surface of the attachment area.

15. The surgical retractor ofclaim 14 wherein the blade includes a guide that directs the elastic tether toward the proximal end of the attachments area.

16. A surgical retractor comprising:

a closed retractor frame having an inner edge; an outer edge; two hinged regions, wherein at least one of the hinged regions includes a thumb-screw or wing-nut based mechanism that when tightened restricts its movement, and a flanged region; and

a bridge member having two edges and two ends, wherein the bridge member further includes a seating region on at least one end that can be attached to the closed retractor frame and a securing structure on at least one end that can be tightened down on by a one thumb-screw or wing-nut associated with the hinged region of the closed retractor frame.

17. The surgical retractor system ofclaim 16, wherein the securing structure is in the shape of a flat open-ended circle.

18. The surgical retractor system ofclaim 16, wherein a seating structure of bridge member is on an opposite side from the securing structure.

19. The surgical retractor system ofclaim 16, wherein a seating structure of bridge member is on both ends of the bridge member.

20. The surgical retractor system ofclaim 16, wherein the bridge member is non-pliable.

21. The surgical retractor system ofclaim 16, wherein the bridge member semi-malleable.

22. The surgical retractor system ofclaim 16, wherein the bridge member is disposable.

23. The surgical retractor system ofclaim 16, wherein the bridge member further includes an internal hinged region to allow the bridge to fold up on itself.

24. The surgical retractor system ofclaim 16, wherein the bridge member is permanently attached to one side of the hinged region of the generally annular frame.